FDA product code QPO: Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples
QPO is the FDA product code for device to preserve and stabilize relative abundances of microbial nucleic acids in clinical samples. It is a Class II device, regulated under 21 CFR 866.2952 and reviewed by the Microbiology panel. Devices under QPO reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it. FDA has posted 6 recalls for QPO devices, 6 initiated in the last five years.
Definition
A device to preserve and stabilize relative abundances of microbial nucleic acids in clinical samples is a device that consists of a container and reagents intended to stabilize microbial nucleic acids for the subsequent assessment of the relative abundance of microbial nucleic acids (i.e., microbiome) in human specimens by an assay validated for use with the device. The device may also be indicated for sample collection. The device is not intended for preserving morphology or viability of microorganisms.
Classification
| Field | Value |
|---|---|
| Device name | Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples |
| Device class | Class II |
| Regulation | 21 CFR 866.2952 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
Recalls for QPO devices
6 product recalls in 1 recall events; 6 initiated in the last five years and 6 still open. Most recent: 2025-11-03.
| Year | Recalls |
|---|---|
| 2025 | 6 |
Frequently asked questions
What is FDA product code QPO?
QPO is the FDA product code for device to preserve and stabilize relative abundances of microbial nucleic acids in clinical samples. It is a Class II device, regulated under 21 CFR 866.2952 and reviewed by the Microbiology panel.
What device class is QPO?
Class II, regulation 21 CFR 866.2952. Typical premarket route: 510(k).
Have QPO devices been recalled?
Yes: 6 product recalls across 1 recall events; the most recent began 2025-11-03.
Next steps
- Run an FDA pathway report with predicate devices for product code QPO
- Run a recall and safety report across every QPO manufacturer
- Watch product code QPO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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